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Journal articles on the topic 'LC-MS/MS bioanalysis'

Author: Grafiati

Published: 4 June 2025

Last updated: 15 July 2025

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1

Arnold, Don W., and Shane R. Needham. "Micro-LC–MS/MS: the future of bioanalysis." Bioanalysis 5, no. 11 (2013): 1329–31. http://dx.doi.org/10.4155/bio.13.31.

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2

Jemal, Mohammed. "High-throughput quantitative bioanalysis by LC/MS/MS." Biomedical Chromatography 14, no. 6 (2000): 422–29. http://dx.doi.org/10.1002/1099-0801(200010)14:6<422::aid-bmc25>3.0.co;2-i.

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3

Li, Xiaotong, Yuanqiang Su, Xinxin Wen, et al. "Rapid adenosine bioanalysis with LS-LC-MS/MS." Drug Metabolism and Pharmacokinetics 61 (June 2025): 101211. https://doi.org/10.1016/j.dmpk.2025.101211.

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4

Deng, Pan, Yan Zhan, Xiaoyan Chen, and Dafang Zhong. "Derivatization methods for quantitative bioanalysis by LC–MS/MS." Bioanalysis 4, no. 1 (2012): 49–69. http://dx.doi.org/10.4155/bio.11.298.

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5

Bergeron, Annik, and Fabio Garofolo. "Importance of matrix effects in LC–MS/MS bioanalysis." Bioanalysis 5, no. 19 (2013): 2331–32. http://dx.doi.org/10.4155/bio.13.237.

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6

van Dongen, William D., and Wilfried MA Niessen. "LC–MS systems for quantitative bioanalysis." Bioanalysis 4, no. 19 (2012): 2391–99. http://dx.doi.org/10.4155/bio.12.221.

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7

Glaser, Vicki. "Optimizing LC/MS for Drug Bioanalysis." Genetic Engineering & Biotechnology News 32, no. 5 (2012): 1–27. http://dx.doi.org/10.1089/gen.32.5.09.

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8

Kotapati, Srikanth, Madhura Deshpande, Aarti Jashnani, Dharam Thakkar, Hongwu Xu, and Gavin Dollinger. "The role of ligand-binding assay and LC–MS in the bioanalysis of complex protein and oligonucleotide therapeutics." Bioanalysis 13, no. 11 (2021): 931–54. http://dx.doi.org/10.4155/bio-2021-0009.

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Ligand-binding assay (LBA) and LC–MS have been the preferred bioanalytical techniques for the quantitation and biotransformation assessment of various therapeutic modalities. This review provides an overview of the applications of LBA, LC–MS/MS and LC–HRMS for the bioanalysis of complex protein therapeutics including antibody–drug conjugates, fusion proteins and PEGylated proteins as well as oligonucleotide therapeutics. The strengths and limitations of LBA and LC–MS, along with some guidelines on the choice of appropriate bioanalytical technique(s) for the bioanalysis of these therapeutic modalities are presented. With the discovery of novel and more complex therapeutic modalities, there is an increased need for the biopharmaceutical industry to develop a comprehensive bioanalytical strategy integrating both LBA and LC–MS.

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9

Zhang, Zhengqi, Yuetian Yan, Shunhai Wang, and Ning Li. "Development of a chromatography-free method for high-throughput MS-based bioanalysis of therapeutic monoclonal antibodies." Bioanalysis 13, no. 9 (2021): 725–35. http://dx.doi.org/10.4155/bio-2021-0021.

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Aim: Our objective was to test the feasibility of developing an LC-free, MS-based approach for high-throughput bioanalysis of humanized therapeutic monoclonal antibodies. Methodology: A universal tryptic peptide from human IgG1, IgG3 and IgG4 was selected as the surrogate peptide for quantitation. After tryptic digestion, the surrogate peptide was fractionated via solid-phase extraction before being subjected to direct infusion-based MS/MS analysis. A high-resolution, multiplexed (MSX = 2) parallel reaction monitoring method was developed for data acquisition. Results & conclusion: This proof-of-concept study demonstrated the feasibility of achieving high-throughput MS-based bioanalysis of monoclonal antibodies using an LC-free workflow with sensitivity comparable to conventional LC–MS/MS-based methods.

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10

Liu, Aowen, Ming Cheng, Yixuan Zhou, and Pan Deng. "Bioanalysis of Oligonucleotide by LC–MS: Effects of Ion Pairing Regents and Recent Advances in Ion-Pairing-Free Analytical Strategies." International Journal of Molecular Sciences 23, no. 24 (2022): 15474. http://dx.doi.org/10.3390/ijms232415474.

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Oligonucleotides (OGNs) are relatively new modalities that offer unique opportunities to expand the therapeutic targets. Reliable and high-throughput bioanalytical methods are pivotal for preclinical and clinical investigations of therapeutic OGNs. Liquid chromatography–mass spectrometry (LC–MS) is now evolving into being the method of choice for the bioanalysis of OGNs. Ion paring reversed-phase liquid chromatography (IP-RPLC) has been widely used in sample preparation and LC–MS analysis of OGNs; however, there are technical issues associated with these methods. IP-free methods, such as hydrophilic interaction liquid chromatography (HILIC) and anion-exchange techniques, have emerged as promising approaches for the bioanalysis of OGNs. In this review, the state-of-the-art IP-RPLC–MS bioanalytical methods of OGNs and their metabolites published in the past 10 years (2012–2022) are critically reviewed. Recent advances in IP-reagent-free LC–MS bioanalysis methods are discussed. Finally, we describe future opportunities for developing new methods that can be used for the comprehensive bioanalysis of OGNs.

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11

Hilhorst, Martijn, Chad Briscoe, and Nico van de Merbel. "Sense and nonsense of miniaturized LC–MS/MS for bioanalysis." Bioanalysis 6, no. 24 (2014): 3263–65. http://dx.doi.org/10.4155/bio.14.263.

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12

Arfvidsson, Cecilia, David Van Bedaf, Susanne Globig, et al. "Improving data integrity in regulated bioanalysis: proposal for a generic data transfer process for LC–MS from the European Bioanalysis Forum." Bioanalysis 12, no. 14 (2020): 1033–38. http://dx.doi.org/10.4155/bio-2020-0156.

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In this paper, the European Bioanalysis Forum reports back from the discussions with software developers, involved in regulated bioanalysis software solutions, on agreeing to data transfer specification in the bioanalytical labs’ LC–MS workflows as part of today’s Data Integrity (DI) challenges. The proposed specifications aim at identifying what consists of a minimum dataset, that is, which are the pre-identified fields to be included in DI proof bidirectional data transfer between LC–MS and information management systems. The proposal is an attempt from the European Bioanalysis Forum to facilitate new software solutions becoming available to increase compliance related to DI in today’s LC–MS workflows. The proposal may also serve as a template and inspiration for new data transfer solutions in other workflows.

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13

Tan, Aimin, and John C. Fanaras. "Use of high-pH (basic/alkaline) mobile phases for LC-MS or LC-MS/MS bioanalysis." Biomedical Chromatography 33, no. 1 (2018): e4409. http://dx.doi.org/10.1002/bmc.4409.

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14

Kaur, Surinder, Kevin P. Bateman, Jim Glick, et al. "IQ consortium perspective: complementary LBA and LC–MS in protein therapeutics bioanalysis and biotransformation assessment." Bioanalysis 12, no. 4 (2020): 257–70. http://dx.doi.org/10.4155/bio-2019-0279.

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Increasingly diverse large molecule modalities have driven the need for complex bioanalysis and biotransformation assessment involving both traditional ligand-binding assays (LBA) and more recent hybrid immunoaffinity LC–MS platforms. Given the scientific expertise in LBA and LC–MS typically resides in different functions within the industry, this has presented operational challenges for an integrated approach for bioanalysis and biotransformation assessment. Encouragingly, over time, the industry has recognized the complementary value of the two platforms. This has not been an easy transition as organizational structures vary widely within the industry. However, there are tremendous benefits in adopting fully integrated strategies for biopharma. This IQ consortium paper presents current perspectives across the biopharma industry. It highlights the technical and operational challenges in current large molecule bioanalysis, the value of collaborations across LBA and LC–MS, and scientific expertise for fully integrated strategies for bioanalysis and biotransformation.

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15

ICHIKAWA, Yoshitaka. "High Throughput LC/MS. Applications in Bioanalysis." Journal of the Mass Spectrometry Society of Japan 49, no. 3 (2001): 96–102. http://dx.doi.org/10.5702/massspec.49.96.

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16

Jemal, Mohammed, and Yuan-Qing Xia. "LC-MS Development Strategies for Quantitative Bioanalysis." Current Drug Metabolism 7, no. 5 (2006): 491–502. http://dx.doi.org/10.2174/138920006777697927.

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17

Rahul, Patil* Rajveer Bhaskar Monika Ola Diksha Pingale Shailesh Chalikwar. "BIOANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION IN HUMAN PLASMA BY USING LC MS/MS." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 03 (2019): 5176–83. https://doi.org/10.5281/zenodo.2591534.

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<em>Bioanalytical method development plays importance role in the pre-clinical and clinical studies. Pharmacokinetics of any drug and its metabolite can be recognized by bioanalytical studies. The quantitative analysis of drugs and their metabolite sin the biological media is done by bioanalytical studies. Physical-chemical and biological techniques are used for these studies. Every bioanalytical method should be selective, sensitive and reliable for the quantitative estimation in drug discovery process. Bioanalytical method development consists of sample preparation, chromatographic separation and detection by using proper analytical method.  Each developed method should be validated as per the regulatory authorities, so as to give reliable and reproducible method for the intended use. Many analytical techniques can be used for bioanalysis; LCMS/MS is one of them. In Liquid chromatography-mass spectrometry [LC-MS/MS] the separation of analyte is done by LC and detection is carried out by MS. LC-MS/MS obviously used in estimation and understanding of bioavailability, bioequivalence and pharmacokinetic data. This review additionally centered on different validation parameters such as: accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery stability, etc.</em> <strong>Keyword: </strong><em>Solid phase extraction, Liquid-Liquid Extraction, cartridge, LC MS/MS, Bioanalysis, Validation.</em>

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18

Ye, Zhengqi, Hong Tsao, Hong Gao, and Christopher L. Brummel. "Minimizing matrix effects while preserving throughput in LC–MS/MS bioanalysis." Bioanalysis 3, no. 14 (2011): 1587–601. http://dx.doi.org/10.4155/bio.11.141.

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19

Needham, Shane R., and Gary A. Valaskovic. "Microspray and microflow LC–MS/MS: the perfect fit for bioanalysis." Bioanalysis 7, no. 9 (2015): 1061–64. http://dx.doi.org/10.4155/bio.15.42.

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20

Qasem, Rani J., Ibrahim K. Frah, Ahmad S. Aljada, and Faisal A. Sehli. "Bioanalysis of plasma acetate levels without derivatization by LC–MS/MS." Bioanalysis 13, no. 5 (2021): 373–86. http://dx.doi.org/10.4155/bio-2020-0294.

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Background: The acetate ion has important physiological functions and important therapeutic applications. A rapid LC–MS/MS method is described to measure acetate ions in human plasma without chemical derivatization. Materials & methods: A 200 μl sample was spiked with the internal standard 1,2-13C-acetate and proteins precipitated with trichloroacetic acid. The supernatant was recovered and separated under acidic conditions on a C18-column. The eluent was alkalinized by post-column infusion of methanolic ammonium hydroxide. Acetate ions were monitored on a low resolution mass spectrometer in negative ion mode. Results: Method was validated for accuracy and precision with a lower limit of quantitation of 9.7 μM and linear dynamic range up to 339.6 μM. Conclusion: The method is open for analytical improvement and adapts with metabolomic and pharmacometabolomic studies on chemicals of similar nature.

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21

Kumar, Devendra, Nagsen Gautam, and Yazen Alnouti. "Analyte recovery in LC-MS/MS bioanalysis: An old issue revisited." Analytica Chimica Acta 1198 (March 2022): 339512. http://dx.doi.org/10.1016/j.aca.2022.339512.

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22

Song, Wei, Joseph A. Tweed, Ravi Visswanathan, James P. Saunders, Zhenhua Gu, and Christopher L. Holliman. "Bioanalysis of Targeted Nanoparticles in Monkey Plasma via LC-MS/MS." Analytical Chemistry 91, no. 21 (2019): 13874–82. http://dx.doi.org/10.1021/acs.analchem.9b03367.

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23

Xu, Raymond Naxing, Leimin Fan, Matthew J. Rieser, and Tawakol A. El-Shourbagy. "Recent advances in high-throughput quantitative bioanalysis by LC–MS/MS." Journal of Pharmaceutical and Biomedical Analysis 44, no. 2 (2007): 342–55. http://dx.doi.org/10.1016/j.jpba.2007.02.006.

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24

S., J. Momin*1 S. R. Shahi2 L. P. Jain3 N. D. Kulkarni4 S. S. Gotpagar5 R. M. Savakhande6. "A Concise Review on Hyphenated Techniques: Liquid Chromatography Coupled Mass Spectroscopy (Lc-Ms/Ms)." International Journal of Pharmaceutical Sciences 3, no. 2 (2025): 1856–68. https://doi.org/10.5281/zenodo.14913274.

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Hyphenated techniques combine spectroscopic and chromatographic methods like LC/MS for toxicology, drug monitoring, pharmacokinetic studies, and bioanalysis with interfaces like APCI and ESI for natural product analysis. Mass spectroscopy (MS) is an analytical technique used to determine the m/e ratio of charged analytes, calculate particle masses, and reveal chemical structures using ionization sources. HPLC and mass spectrometry coupling is complex due to high vacuum requirements, but interfaces like TSP, CFAB, API, and ESI overcome this, integrating detectors with liquid chromatographic separations. LC-MS is one of the hyphenated analytical methods that combine mass spectrometry and liquid chromatography for complex mixture analysis in biological, environmental, and pharmacological materials. It includes mobile phase reservoirs, pumps, degassers, auto samplers, columns, and detectors, with UV being the most common for stability and sensitivity. During the optimization stage, initial conditions such as resolution, peak shape, plate counts asymmetry, capacity factor, elution time, detection limits, limit of quantification, and overall analyte quantification ability are optimized. LC-MS/MS is a popular bioanalysis method for measuring medication concentrations in biological samples, making it the preferred quantitative analysis method between drug discovery and development. Validation of method by various parameters like accuracy precision etc. Applications of LC-MS in various fields like in structural elucidation.

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25

Kleinnijenhuis, Anne J., Frédérique L. van Holthoon, and William D. van Dongen. "Integrated hemolysis monitoring for bottom-up protein bioanalysis." Bioanalysis 12, no. 17 (2020): 1231–41. http://dx.doi.org/10.4155/bio-2020-0175.

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Background: Hemolysis can result in analyte suppression or enhancement and it can affect the extraction efficiency and analyte stability. Triskelion developed an LC–MS method to monitor hemolysis. The concept can be integrated into existing and new quantitative protein LC–MS methods and can be validated according to the most appropriate tier. Results/methodology: In this proof of concept study, the tryptic target LLVVYPWTQR was used to quantify hemoglobin. The peptide target has only few variations considering the most common (laboratory) animals and is thus nearly generic. It was shown that LC–MS is a suitable technique for the quantification of hemoglobin in hemolyzed samples and that the signals are not affected by lipemia. Conclusion: LC–MS exhibited the best performance to monitor hemolysis when the results were compared with UV–VIS and visual inspection, especially when samples were lipemic.

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26

da Mota Castelo Branco, Daniel, Noely Camila Tavares Cavalcanti Bedor, Carolina Santos Silva, Danilo César Galindo Bedor, Maria Fernanda Pimentel, and Davi Pereira de Santana. "Quality by design applied to olanzapine and quetiapine LC-MS/MS bioanalysis." Journal of Chromatographic Science 58, no. 2 (2020): 117–26. http://dx.doi.org/10.1093/chromsci/bmz083.

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Abstract One major challenge in quantifying drugs in biological matrices is to manage interfering compounds. A technique such liquid chromatography coupled to mass spectrometry in tandem (LC-MS/MS) is especially suitable for this application due to its high sensitivity and selectivity in detecting low concentrations of analytes in a complex system. Due to the complexity of LC-MS/MS systems, a number of experimental parameters must be optimized to provide an adequate separation and detection of the analyte. In the present work, a design of experiments approach was developed to optimize an LC-MS/MS-based bioanalytical method to extract olanzapine (OLZ) and quetiapine (QTP) from human plasma. Three steps for the optimization process were conducted: central composite face-centered design to optimize chromatographic parameters (Step 1), ionization in mass spectrometry (Step 2) and a full 32 factorial design to optimize analyte extraction conditions (Step 3). After the optimization process, resolutions and QTP and OLZ retention time (2.3 and 4, respectively) were optimum with pH of 4.7 and 85.5% of acetonitrile for the chromatographic step. Mass spectrometry optimization step provided an increase of (±50%) in the average peak area with high signal-to-noise relationship for the analytes studied. The proposed extraction method was 70% more efficient than the initial method for all drugs analyzed.

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27

TOYO’OKA, Toshimasa. "Derivatization-based High-throughput Bioanalysis by LC-MS." Analytical Sciences 33, no. 5 (2017): 555–64. http://dx.doi.org/10.2116/analsci.33.555.

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28

Guo, Xinghua, and Ernst Lankmayr. "Phospholipid-based matrix effects in LC–MS bioanalysis." Bioanalysis 3, no. 4 (2011): 349–52. http://dx.doi.org/10.4155/bio.10.213.

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29

Tang, Daniel, and Elizabeth Thomas. "Strategies for dealing with hemolyzed samples in regulated LC–MS/MS bioanalysis." Bioanalysis 4, no. 22 (2012): 2715–24. http://dx.doi.org/10.4155/bio.12.229.

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30

Roy, Bratati, and C. P. Malik. "Stability of Analyte – A Big Concern while Bioanalysis through LC–MS/MS." LS: International Journal of Life Sciences 5, no. 1 (2016): 25. http://dx.doi.org/10.5958/2319-1198.2016.00005.1.

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31

Panda, Sagar Suman. "Bioanalysis of anticancer agents: Evaluating LC-MS/MS procedures with greenness metrics." TrAC Trends in Analytical Chemistry 169 (December 2023): 117394. http://dx.doi.org/10.1016/j.trac.2023.117394.

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32

Kellie, John F. "Intact protein LC–MS for pharmacokinetics." International Journal of Pharmacokinetics 4, no. 4 (2019): IPK05. http://dx.doi.org/10.4155/ipk-2020-0004.

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Biography: John Kellie is currently a GlaxoSmithKline (GSK) fellow in the Bioanalysis, Immunogenicity, and Biomarkers group at GSK. John received his B.Sc. in Biochemistry from Indiana University (USA) and his PhD in Chemistry from Northwestern University (USA) studying under Dr Neil Kelleher. He was a post-doctoral scientist at Eli Lilly and Company, where he developed methods for intact protein quantitation of a Parkinson’s Disease biomarker from human brain tissue. At GSK, John utilizes mass spectrometry for development of novel bioanalytical methods for biotherapeutic and protein quantitation from pre-clinical and clinical samples, with a focus on intact protein and large mass quantitation for pharmacokinetics, catabolism, biotransformation and product quality attribute support. John Kellie speaks to the International Journal of Pharmacokinetics about intact protein LC–MS for pharmacokinetic application.

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33

Hashii, Noritaka, Yoshiko Tousaka, Koji Arai, et al. "Bioanalysis of therapeutic monoclonal antibody by peptide adsorption-controlled LC–MS." Bioanalysis 13, no. 4 (2021): 265–76. http://dx.doi.org/10.4155/bio-2020-0262.

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Aim: We aimed to develop an easy, low-cost and versatile mass spectrometric method for the bioanalysis of a therapeutic monoclonal antibody (mAb) in human serum that employs peptide adsorption-controlled (PAC)-LC/MS using selected reaction monitoring mode (LC–MS/MS-SRM). Materials & methods: Rituximab was used as a model mAb. To apply the method to human serum samples, a peptide of the complementarity-determining region was selected as the surrogate peptide. The usefulness of PAC-LC–MS/MS-SRM was evaluated by a collaborative study. Results: The calibration curve ranged from 0.5 (or 1.0) to 1000.0 μg/ml. The selectivity, linearity, accuracy and precision met the predefined acceptance criteria. Conclusion: Our method could be a useful bioanalytical method for the quantification of mAbs in clinical samples.

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34

Koster, Remco, Henk Van der Lijke, and Peter Pruim. "The impact of decreased LC–MS/MS run times on small molecule bioanalysis." Bioanalysis 13, no. 6 (2021): 409–13. http://dx.doi.org/10.4155/bio-2020-0334.

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35

Zhang, Jun, Wilson Shou, Tairo Ogura, Shu Li, and Harold Weller. "Optimization of microflow LC–MS/MS and its utility in quantitative discovery bioanalysis." Bioanalysis 11, no. 11 (2019): 1117–27. http://dx.doi.org/10.4155/bio-2019-0076.

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36

Meng, Min, Laixin Wang, Troy Voelker, Scott Reuschel, KC Van Horne, and Patrick Bennett. "A systematic approach for developing a robust LC–MS/MS method for bioanalysis." Bioanalysis 5, no. 1 (2013): 91–115. http://dx.doi.org/10.4155/bio.12.295.

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37

Shin, Soyoung, Sun-Mi Fung, Srinidi Mohan, and Ho-Leung Fung. "Simultaneous bioanalysis of l-arginine, l-citrulline, and dimethylarginines by LC–MS/MS." Journal of Chromatography B 879, no. 7-8 (2011): 467–74. http://dx.doi.org/10.1016/j.jchromb.2011.01.006.

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38

Wang, Yan. "Development of a quantitative method for rat bile bioanalysis using LC-MS/MS." Drug Metabolism and Pharmacokinetics 32, no. 1 (2017): S44—S45. http://dx.doi.org/10.1016/j.dmpk.2016.10.188.

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39

Tan, Aimin, and John C. Fanaras. "How much separation for LC–MS/MS quantitative bioanalysis of drugs and metabolites?" Journal of Chromatography B 1084 (May 2018): 23–35. http://dx.doi.org/10.1016/j.jchromb.2018.03.019.

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40

Rossi, David T. "Integrating automation and LC/MS for drug discovery bioanalysis." Journal of Automated Methods and Management in Chemistry 24, no. 1 (2002): 1–7. http://dx.doi.org/10.1155/s1463924602000019.

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A novel, integrated approach for automated sample handling in drug discovery bioanalysis is described. The process includes aspects of animal study design, biological sample collection, sample processing and high-throughput APILC/MS operating in under multiple reaction monitoring (MRM). A semi-automated 96-well liquid—liquid extraction technique for biological fluid sample preparation was developed and used in conjunction with the integrated sample-handling approach. One plate of samples could be prepared within 1.5 h compared with 4 h for a manual approach, and the resulting 96-well plate of extracts was directly compatible with the LC/MS. Feasibility studies for the development of the process included sample collection map generation and information management, sample collection formatting, evaluation of alternative dilution schemes for high-concentration samples, choice of biological fluid, and evaluating the capabilities of the two liquid-handling workstations. Numerous comparisons between the new approach and conventional sample-handling approaches gave equivalent drug-quantitation results for several example compounds. This new sampling process has approximately doubled the efficiency (as measured by studies assayed per month) of drug discovery bioanalysis in our laboratory. The approach was also used in conjunction with time-of-flight mass spectrometry instrumentation (LC/TOF/MS) to quantify and characterize the disposition of simultaneously dosed example drug compounds in the rat. Likely strategies for future automated sample preparation workstations are described.

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41

Guo, Xinghua, and Ernst Lankmayr. "Multidimensional approaches in LC and MS for phospholipid bioanalysis." Bioanalysis 2, no. 6 (2010): 1109–23. http://dx.doi.org/10.4155/bio.10.52.

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42

Zhou, Wanlong, and Perry G. Wang. "Cosmetic bioanalysis using LC–MS: challenges and future outlook." Bioanalysis 6, no. 4 (2014): 437–40. http://dx.doi.org/10.4155/bio.13.246.

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43

van de Merbel, Nico C., Oladapo Olaleye, Baubek Spanov, and Rainer Bischoff. "Large molecule bioanalysis by LC–MS: beyond simply quantifying." Bioanalysis 14, no. 7 (2022): 397–400. http://dx.doi.org/10.4155/bio-2022-0032.

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44

Rossi, David T. "Integrating automation and LC/MS for drug discovery bioanalysis." Journal of Automated Methods & Management in Chemistry 24, no. 1 (2002): 1–7. http://dx.doi.org/10.1080/14639240110092567.

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45

Cantone, Joseph L., Zeyu Lin, Ira B. Dicker, and Dieter M. Drexler. "Normalization strategy for the LC-MS bioanalysis of protein kinetics assays via internal proteolytic analyte utilized as control standard: application in studies of HIV-1 protease cleavage of HIV-1 Gag polyprotein in HIV maturation inhibition research." Analytical Methods 9, no. 35 (2017): 5219–25. http://dx.doi.org/10.1039/c7ay01666b.

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46

Bhusarapu, Satya Prasad, and Jaya Kumari Sekharan. "Estimation of Eravacycline Dihydrochloride in Biological Matrices by LC-MS/MS." Pharmaceutical Methods 10, no. 2 (2019): 6. https://doi.org/10.5281/zenodo.14586110.

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Objective: The validated protein precipitation method was applied for estimation of Eravacycline dihydrochloride in human plasma with Rolitetracycline hydrochloride as an internal standard (ISTD) by using HPLC-ESI-MS/ MS. Methods: The chromatographic separation was achieved with 20mM Ammonium acetate (pH-3.0):Methanol:Acetontrile (20:20:60,%v/v) using the TELOS LU C18 (2) 5µm, 100 x 4.6 mm. The total analysis time was 3 min and flow rate was set to 0.5 mL/min. Results: The mass transitions of Eravacycline dihydrochloride and Rolitetracycline hydrochloride obtained were m/z 632.5®84.3 and 436.2®84.3. The standard curve shows correlation coefficient (s) greater than 0.999 with a range of 15.00-120.00 pg/ml using the linear regression model. Conclusion: The method was suitableand conveniently applicable to pharmacokinetic and bioavailability studies for estimation of Eravacycline in biological matrices by HPLC-ESI-MS/MS.

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47

Fu, Yunlin, Deborah Barkley, Wenkui Li, Franck Picard, and Jimmy Flarakos. "Evaluation, identification and impact assessment of abnormal internal standard response variability in regulated LC−MS bioanalysis." Bioanalysis 12, no. 8 (2020): 545–59. http://dx.doi.org/10.4155/bio-2020-0058.

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Internal standard (IS) plays an important role in LC−MS bioanalysis by compensating for the variability of the analyte of interest in bioanalytical workflow. Due to the complexity of biological sample compositions and bioanalytical processes, a certain level of IS response variability across a run or a study is anticipated. However, an extensive variability may raise doubts to the accuracy of the measured results and also suggest nonoptimal analytical method. In this current paper, recent publications and guidelines regarding IS response in LC−MS bioanalysis were thoroughly reviewed with focus on the evaluation, identification and impact assessment of ‘abnormal’ IS response variability. A systematic decision tree was proposed to facilitate investigation into abnormal IS response variability after each run.

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Fraier, Daniela, Luca Ferrari, Katja Heinig, and Elke Zwanziger. "Inconsistent internal standard response in LC–MS/MS bioanalysis: an evaluation of case studies." Bioanalysis 11, no. 18 (2019): 1657–67. http://dx.doi.org/10.4155/bio-2019-0127.

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Aim: Monitoring the internal standard (IS) response is common practice in bioanalysis by LC–MS/MS. IS response variation may raise questions on assay quality and should trigger investigations into the root cause. Results: In two case studies with IS variability, re-analysis of diluted samples and spiking predose study samples revealed no effect of IS variability on results. The D17-labeled IS in a third case proved not to be suitable during method development and was replaced by a differently labeled IS. Conclusion: Determining the exact root cause for varying IS response is not always feasible; however, assay accuracy and reliability of results should be demonstrated. In some cases, assay re-development is needed to solve the problem.

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Li, Wenkui, Jim Glick, Panos Hatsis, et al. "An integrated outsourcing practice of nonclinical LC–MS bioanalysis and toxicokinetics at Novartis small molecule drug development." Bioanalysis 13, no. 12 (2021): 1001–10. http://dx.doi.org/10.4155/bio-2021-0072.

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With decommissioning of internal regulated bioanalytical (BA) and toxicokinetic (TK) capabilities, Novartis has relied on external service providers (ESPs) for all nonclinical LC–MS BA and majority of the associated TK work since 2017. This paper outlines an integrated outsourcing practice of the Novartis nonclinical LC–MS BA/TK group, which covers the roles and responsibilities of Novartis nonclinical LC–MS BA/TK expert scientific monitors, selection of ESPs for Novartis nonclinical LC–MS BA/TK studies, qualification of BA/TK ESPs, study conduct and completion, ESP oversight and evaluation, issue mitigation, and future perspectives.

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Koster, Remco A. "Have we got ‘patient-centric sampling’ right?" Bioanalysis 12, no. 13 (2020): 869–72. http://dx.doi.org/10.4155/bio-2020-0146.

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RA Koster currently works as Associate Director of Bioanalytical Science at the LC–MS/MS department at PRA Health Sciences in the Laboratory in Assen, The Netherlands. He is responsible for the LC–MS/MS analytical method development and leads a team of method development analysts and scientists. As global microsampling specialist within PRA he is interested in all developments regarding microsampling and aims to continuously improve microsampling techniques. He has been working in the field of bioanalysis for 19 years, in which he performed and supervised numerous analytical method developments using LC–MS/MS. He started his career in 2001 at Pharma Bio-Research (before it was acquired by PRA) as an LC–MS/MS analyst. In 2005, he moved to the University Medical Center Groningen where he focused on the development and validation of analytical methods for drugs and drugs of abuse in matrices like blood, plasma, hair, saliva, dried blood spots and volumetric absorptive microsampling with LC–MS/MS. In 2015 he obtained his PhD on the subject ‘The influence of the sample matrix on LC–MS/MS method development and analytical performance’. In 2017, he started as Senior Scientist at PRA Health Sciences and in 2019, he accepted his current role of Associate Director of Bioanalytical Science. He is a (co-)author of more than 35 publications.

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